Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 202-723-9 | CAS number: 99-04-7
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 1981-05-12
- Deviations:
- yes
- Remarks:
- pH not evaluated, observation after 30-60 min not conducted; Exposure conditions were more intesive than required by the OECD guideline 404 , in respect of duration and coverage. Each animal was treated at clipped intact as well as abraded skin sites.
- Principles of method if other than guideline:
- Exposure conditions were more intensive than required by OECD Guideline 404 such that appliction duration was 24 hours hours instead of 4 hours under, type of coverage was occlusive instead of semiocclusive and each of 6 animals was treated at clipped intact as well as abraded skin sites.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- m-toluic acid
- EC Number:
- 202-723-9
- EC Name:
- m-toluic acid
- Cas Number:
- 99-04-7
- Molecular formula:
- C8H8O2
- IUPAC Name:
- m-toluic acid
- Test material form:
- solid: flakes
- Details on test material:
- - Appearance: light yellow flakes
- Molecular weight: 136.1
- Density: 1.04 g/cm³ (112 °C)
- Flash point: 147 °C
- Boiling point: 263 °C
- Melting point: 111.7 °C
Constituent 1
- Specific details on test material used for the study:
- TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: pulverisation with mortar, moistened with distilled water
Test animals
- Species:
- rabbit
- Strain:
- other: Kbs:JW
- Remarks:
- japanese white rabbit
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Kitayama Labes Co., Ltd.
- Weight at study initiation: 2.1 - 2.5 kg
- Diet (ad libitum): solid feed RC-4 (obtained from Oriental Yeast K.K)
- Water ( ad libitum): tap water
- Acclimation period: 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 ± 2 °C
- Humidity (%): 55 ± 6 %
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: clipped, partly left intact, partly abraded (stratum corneum was removed with injection needles)
- Vehicle:
- other: distilled water
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g per application site, clipped intact as well as abraded skin areas were treated at each animal. - Duration of treatment / exposure:
- 24 hours
- Observation period:
- 7 days
- Number of animals:
- 6 male animals
- Details on study design:
- TEST SITE
- Area of exposure: within a circle of 3 cm (according to 7 cm²)
- Type of wrap if used: two layers of gauze patch fixed in a closed patch with Tegaderm (3M) and Ju Picot 5 (obtained from Tokyo Material Research Institute)
REMOVAL OF TEST SUBSTANCE
- removal with gauze soaked in water
OBSERVATION TIME POINTS
- daily after application period. Reported values for 24, 48, 72 and 168 hours
SCORING SYSTEM:
- Method of calculation: scoring of erythema and edema was conducted according to Draize method after 24, 48, 72 and 168 hours.
(Please refer to the field 'Any other information on materials and methods incl. tables')
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: intact skin; 24 hour occlusive exposure
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: intact skin; 24 hour occlusive exposure
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: intact skin; 24 hour occlusive exposure
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: intact skin; 24 hour occlusive exposure
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: intact skin; 24 hour occlusive exposure
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: intact skin; 24 hour occlusive exposure
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: intact skin; 24 hour occlusive exposure
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: intact skin; 24 hour occlusive exposure
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: intact skin; 24 hour occlusive exposure
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: intact skin; 24 hour occlusive exposure
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: intact skin; 24 hour occlusive exposure
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: intact skin; 24 hour occlusive exposure
- Other effects:
- no effects observed
Any other information on results incl. tables
Table 1: Results
Items |
Erythema |
Oedema |
||
Observation time |
24 |
72 |
24 |
72 |
Rabbit No. |
|
|
|
|
1 int |
0 |
0 |
0 |
0 |
Abr |
0 |
0 |
0 |
0 |
2 int |
0 |
0 |
0 |
0 |
Abr |
0 |
0 |
0 |
0 |
3 int |
0 |
0 |
0 |
0 |
Abr |
1 |
0 |
0 |
0 |
4 int |
1 |
0 |
0 |
0 |
Abr |
1 |
0 |
0 |
0 |
5 int |
0 |
0 |
0 |
0 |
Abr |
0 |
0 |
0 |
0 |
6 int |
0 |
0 |
0 |
0 |
abr |
0 |
0 |
0 |
0 |
Int: intact skin
Abr: abraded skin
1 out of 6 rabbits displayed at the intact site and 2 out of 6 rabbits displayed at the abraded skin sites mild erythema (Draize score 1) after 24 hours, which was reversible after 48 hours.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance is non-irritating to the skin.
According to the EC-Regulation 1272/2008 and subsequent regulations, the test item is not classified as skin irritant.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.